German Trial Shows Reduced Risk of Venous Thromboembolism With Prophylactic Enoxaparin in Ambulatory Patients With Advanced Pancreatic Cancer
In the German CONKO-004 trial reported in the Journal of Clinical Oncology, Pelzer et al found that prophylactic treatment with the low-molecular-weight heparin enoxaparin reduced the risk of symptomatic venous thromboembolic events in ambulatory patients receiving first-line chemotherapy for advanced pancreatic cancer.
Study Details
In this open-label trial, 312 patients were randomly assigned, depending on Karnofsky performance status and serum creatinine level, to receive gemcitabine, fluorouracil, leucovorin, and cisplatin with or without enoxaparin 40 mg/d or gemcitabine with or without enoxaparin. In total, 160 patients were randomly assigned to enoxaparin and 152, to observation.
Venous Thromboembolic Events and Major Bleeds
Within the first 3 months of follow-up, symptomatic venous thromboembolic events occurred in 2 patients (1.25%) in the enoxaparin group and 15 patients (9.9%) in the observation group (hazard ratio [HR] = 0.12, P = .001). Major bleeding events occurred in seven patients (4.4%) in the enoxaparin group and five patients (3.3%) in the observation group (HR = 1.4, P = 1.0). The overall cumulative incidence rate of symptomatic venous thromboembolic events was 6.4% in the enoxaparin group vs 15.1% in the observation group (HR = 0.40, P = .01), and the overall cumulative incidence rate of major bleeds was 8.3% vs 6.9% (HR = 1.23, P= .63).
The enoxaparin and observation groups did not differ with regard to progression-free (HR = 1.06, P = .64) or overall survival (HR = 1.01, P = .44).
The investigators concluded: “This study demonstrates the high efficacy and feasibility of primary pharmacologic prevention of symptomatic [venous thromboembolic events] in outpatients with [advanced pancreatic cancer]. Treatment efficacy was not affected by simultaneous treatment with enoxaparin in this trial setting.”
Uwe Pelzer, MD, of Charité-Universitätsmedizin Berlin, is the corresponding author of the Journal of Clinical Oncology article.
The study was supported by Charité-Forschungsförderung, Arbeitsgemeinschaft Internistische Onkologie, Deutsche Krebsgesellschaft, Amgen, Eli Lilly, and Sanofi-Aventis. For full disclosures of the study authors, visit jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
